PRF for Accelerating Palatal Healing
The Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial
1 other identifier
interventional
125
0 countries
N/A
Brief Summary
Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 18, 2016
CompletedMarch 18, 2016
March 1, 2016
1.5 years
March 9, 2016
March 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Epithelialization
Assessed according to the toluedine blue coloring
One month
Secondary Outcomes (5)
Sensibility disorders
One month
feeding habits
One month
Delayed bleeding
1 week
Immediate Bleeding
1 hour
Pain
3 months
Study Arms (3)
Platelet Rich Fibrin
EXPERIMENTALPRF was laid directly on the palatal wound immediately after harvesting the tissue graft and stabilized
Butyl cyanoacrylate
ACTIVE COMPARATORButyl cyanoacrylate was directly applied on the palatal wound after harvesting the tissue graft
Wet Gauze
PLACEBO COMPARATORWet Gauze was placed for 1 minute on the palatal wound after harvesting the tissue graft
Interventions
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.
Eligibility Criteria
You may qualify if:
- no contraindications for periodontal surgery;
- full-mouth plaque score of \<10%
- full-mouth bleeding score of \<15%.
You may not qualify if:
- previously undergone surgery for a graft harvested from the palate
- presence of systemic disease or taking medication known to interfere with periodontal health
- smokers
- possible coagulation disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Onur Ozcelik, Ph D
Cukurova University, Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 18, 2016
Study Start
November 1, 2013
Primary Completion
May 1, 2015
Study Completion
September 1, 2015
Last Updated
March 18, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share